News

The latest updates on vaccine safety projects and products from the Brighton Collaboration community

(Total Items: [sbs_posts cat="news"])

Lessons Learned from Vaccine Safety Surveillance Efforts

Much has been learned about the need for vaccine safety surveillance through COVAX and other recent collaborative efforts. Here, we highlight three recent publications that share lessons learned in active vaccine safety surveillance (AVSS). SARS-CoV-2 vaccine-related adverse events in Zimbabwe: The need to strengthen pharmacovigilance in resource-limited settings (Pharmacoepidemiology and Drug Safety) This letter discusses various strategies for strengthening pharmacovigilance in Zimbabwe, a limited resource country, using tailored, robust reporting or other pharmacoepidemiological methods that systematically collect and analyze adverse

Dr. Punnee Pitisuttithum: Engaging community in active vaccine safety surveillance

A member of both Brighton Collaboration and the Safety Platform for Emergency vACcines project’s Meta-DSMB, Dr. Punnee Pitisuttithum not only has extensive experience serving on Data and Safety Monitoring Boards (DSMBs) but also as a principal investigator at vaccine clinical trial sites. Through her roles in clinical trials for HIV, dengue, and chikungunya vaccines, Dr. Pitisuttithum has contributed to the implementation of active vaccine safety surveillance activities that build relationships and trust at the community level. Dr. Pitisuttithum was a

Request for Review: Vaccine Safety Template – IDT Bio Manuscript

The proposed IDT Modified Vaccinia virus Ankara viral vector vaccine manuscript is ready for peer review. The Brighton Collaboration BRAVATO (Benefit-Risk Assessment of VAccines by TechnolOgy) Working Group encourages members with experience in Benefit-Risk or viral vector technology to peer review this template by the end of the day Friday, August 2, 2024. Please provide feedback via this form > The manuscript is as follows and is available for download. Should you want to provide comments within the document, please

Request for Review: Vaccine Safety Template for Clover COVID-19 recombinant protein vaccine

The proposed Clover COVID-19 recombinant protein vaccine manuscript is ready for peer review. The Brighton Collaboration BRAVATO (Benefit-Risk Assessment of VAccines by TechnolOgy) Working Group encourages members with experience in Benefit-Risk or recombinant protein technology to peer review this template by the end of the day Wednesday, July 17th, 2024. Please provide feedback via this form > The manuscript is as follows and is available for download. Should you want to provide comments within the document, please send your revised

Ensuring the safety of dengue vaccines: Alejandro Cravioto brings international expertise to the Pan-American Advisory Committee on Vaccine Safety

The World Health Organization (WHO) has reported a ten-fold increase in dengue cases over the past twenty years. Today, nearly 4 billion people are at risk of dengue infection. The WHO has licensed two vaccines for dengue—Dengvaxia, developed by Sanofi Pasteur, and Qdenga, developed by Takeda. Both have been shown to be effective in preventing types one and two of four total types of dengue virus. Brighton Collaboration Science Board member, Dr. Alejandro Cravioto, is supporting the Pan-American Advisory Committee

Dr. Eileen Farnon joins Brighton Collaboration as Research Director

The Task Force for Global Health welcomes Dr. Eileen Farnon as Brighton Collaboration’s new Research Director. Dr. Farnon, who is trained in clinical infectious diseases, tropical medicine, and applied epidemiology, brings more than 20 years of experience in public health, including outbreak response and clinical research and development, to the Brighton Collaboration and the SPEAC project. Dr. Farnon first became interested in vaccine safety in 2005 while working as an Epidemic Intelligence Service (EIS) officer in the Arboviral Diseases branch

Lessons Learned and Key Recommendations from the COVAX Vaccine Safety Working Group

The Vaccine Safety Working Group (VSWG) of COVAX was formed in November 2020 with representatives and consultants representing multiple stakeholders, including Brighton Collaboration, Developing Countries Vaccine Manufacturers Network (DCVMN), International Federation of Pharmaceutical Manufacturers and Associations, WHO and Coalition for Epidemic Preparedness Innovations (CEPI). Its primary objectives were to act as an open source of information for vaccine developers, to resolve common vaccine safety cross-project questions and challenges at speed, and to facilitate coordination within the ecosystem to maximize impact.

COVID-19 Safety Studies project offers evidence to support increasing active vaccine safety surveillance in low- and middle-income countries

Vaccine safety data can help build public confidence in vaccines by communicating that the benefits outweigh the risks of immunization. Through the COVID-19 Safety Studies project, researchers aimed to identify gaps in the regional availability of safety data for COVID-19 vaccines. The findings offer a step toward building vaccine safety surveillance capacity in low- and middle-income countries in preparation for the next pandemic. The COVAX vaccine safety working group, the Coalition for Epidemic Preparedness Innovations (CEPI), and the WHO Pharmacovigilance team

99 Million People Included in Largest Global Vaccine Safety Study

Global Vaccine Data Network utilises vast data sets to detect potential vaccine safety signals 19 February 2024—The Global Vaccine Data Network (GVDN) assessed 13 neurological, blood, and heart related medical conditions to see if there was a greater risk of them occurring after receiving a COVID-19 vaccine. This was one of eight studies in the Global COVID Vaccine Safety (GCoVS) Project. Recently published in the journal Vaccine, this observed versus expected rates study included 99 million people (over 23 million

Request for Review: Standardized template with key considerations for a benefit/risk assessment for the Comirnaty COVID-19 mRNA vaccine

The proposed mRNA BioNTech/Comirnaty manuscript is ready for peer review. The Brighton Collaboration BRAVATO (Benefit-Risk Assessment of VAccines by TechnolOgy) Working Group encourages the Brighton Collaboration community to peer review this template by the end of the day Tuesday, February 20th, 2024. View the manuscript: A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Comirnaty COVID-19 mRNA vaccine to prevent disease caused by SARS-CoV-2 viruses Click here to complete the peer review form >

New University of Alberta-based study to examine very rare adverse events linked to COVID-19 vaccines

The multimillion-dollar global initiative will study causes and risk factors, to ensure safer vaccines are ready for the next potential pandemic. EDMONTON — A University of Alberta professor is co-leading a new international vaccine safety network to examine why some people who received a COVID-19 vaccine experienced very rare adverse events associated with the vaccine. The International Network of Special Immunization Services (INSIS), based at the U of A, is a consortium of academic medical centres around the world coming

SPEAC’s Real-World Evidence Framework

This editorial by Dr. Robert T. Chen first appeared in the October 2023 issue of Safety by Numbers. It is reposted here with permission from GVDN.  Historically, much of the safety assessment of a new vaccine was deferred to post-introduction. Safety assessments within pre-approval clinical trials tended to be separate from post-approval Real-World Evidence (RWE). There were barriers to implementing a vaccine lifecycle approach, including a disconnect between separate teams and staff for pre- versus post-approval. Applicability in low- and middle-income countries

Request for Review: TTS-VITT Draft Brighton Case Definition

Dear Brighton Collaboration members: Please find below a draft Brighton Collaboration case definition for both TTS (thrombosis and thrombocytopenia syndrome) and VITT (vaccine-induced thrombocytopenia and thrombosis). The online review survey will ask about each case definition level of certainty (TTS and VITT) separately. The proposed TTS case definition is a revision of the version posted to the Brighton Collaboration website in Nov 2021. There are two reasons for having two separate case definitions. The VITT CD is very specific and

Understanding the Etiologies of Adverse Events Following Immunization via the International Network of Specialist Immunization Services

This editorial was previously published in Vaccine Safety Quarterly. Karina Top, MD, MS Vaccine safety has been my primary research focus for over a decade.  I established the Canadian Special Immunization Clinic Network with Drs. Gaston De Serres (Laval University) and Scott Halperin (Dalhousie University) in 2013, which I continue to lead. I have also been a member of the Brighton Collaboration since that time and contributed to the development of several case definitions.  In Fall 2020, recognizing the need for

Request for Review: Autoimmune Hepatitis Case Definition

On behalf of the Brighton Collaboration Autoimmune Hepatitis Case Definition Working Group, please find below a manuscript on “Autoimmune hepatitis: Brighton Collaboration case definition and guidelines for data collection, analysis, and presentation of immunisation safety data”. It has been developed on an expedited basis as autoimmune hepatitis is an adverse event of special interest. There have been reports of autoimmune hepatitis developing following COVID-19 infection, including in unvaccinated patients. The Working Group has members with significant clinical (adult and paediatric

Maternal Immunization Working Group Meeting Report (November 2022)

On 8 and 9 November 2022, the Maternal Immunization Working Group (MIWG) held an in-person and online hybrid meeting. The objectives of the meeting were to provide an opportunity to share new data regarding maternal immunization, to discuss the landscape of vaccines under development for use in pregnant women, and to consider how new vaccines, such as RSV and GBS, will be integrated into immunization programs for pregnant women. Click here to view the full working group meeting report.

COVID-19 AESI List 5th Update – October 2022

SPEAC has completed a fifth update to the Priority List of potential Adverse events of special interest relevant to COVID-19 vaccine trials.  Past updates focused on COVID-19 disease course and complications whereas this one shifts the emphasis to what has been observed for COVID-19 vaccines currently in use. It is limited to countries with pharmacovigilance programs in place that are able to monitor large populations (United States, Canada, Australia, United Kingdom, European Union). http:brightoncollaboration.org/wp-content/uploads/2023/08/Updated-COVID-19-AESI-list_Oct2022-1.pdf

International Society of Pharmacoepidemiology (ISPE) COVID19-related Award: Robert T. Chen MD MA FISPE

We are proud to announce that Dr. Bob Chen, Scientific Director of the Brighton Collaboration, received a special award for “Contributions to Public Health Associated with the COVID-19 Pandemic” from the International Society of Pharmacoepidemiology (ISPE) at its 38th annual meeting in Copenhagen, Denmark on August 27, 2022. http:brightoncollaboration.org/wp-content/uploads/2023/08/ISPE-COVID19-Award.Chen_.2022.08.2746817-2.pdf

Director of Research – Brighton Collaboration

To help meet its increasing needs, the Secretariat for the Brighton Collaboration (BC) has recently posted a new staff position: Director of Research. The position description and link to apply can be found at the following link: Job Posting  (see below for a summary). The Brighton Collaboration is now one of the programs of the Task Force for Global Health’s Center for Vaccine Equity.  Emory University manages the Human Resources for the Task Force for Global Health. The Director of Research for the

CEPI Sponsored DSMB Training Course

Coalition for Epidemic Preparedness Innovations (CEPI) through the Safety Platform for Emergency vACcines (SPEAC) project, has funded the development of a training program for potential Data and Safety Monitoring Board (DSMB) participation which will prioritize participants from low and middle-income countries (LMIC). CEPI has an expanding portfolio which is currently funding the development of several vaccines for Lassa fever, Chikungunya, Rift Valley fever, MERS, Nipah and COVID-19. Since trials for these vaccines as well as others will be conducted in countries where

WHO & COVAX Vaccine Safety Working Group Active Vaccine Safety Surveillance Survey

On behalf of the COVAX Vaccine Safety Working group: After COVID-19 vaccines are introduced into countries, it will be vital to generate real-world data on vaccine safety following immunization, as many questions will remain unanswered by the clinical trials. Active Vaccine Safety Surveillance (AVSS) will likely be conducted in a variety of countries, in a variety of populations, and using a variety of study designs. We are reaching out to you as you or persons you know/work with may be conducting these

Brighton Collaboration Science Board Election Announcement

The current Brighton Collaboration Science Board has voted to accept all 16 candidates onto the new Brighton Collaboration Science Board. After consideration of all the candidates and given current unique circumstances, the nominating committee (consisting of the 3 outgoing SB members) proposed that all candidates be appointed to a provisional Science Board for the next two years rather than have an election that would result in only 10 of the 16 being appointed to the board. Click here to download the

COVID-19 AESI List 4th Update – August 2021

SPEAC has completed a 4th update of the COVID-19 clinical literature covering the period from November 2020 – August 2021. Click HERE to view the COVID-19 AESI list. The primary objectives were to review the evidence on the following outcomes: Long COVID (click here to view); acute cardiac injury other than myocarditis/pericarditis; maternal, foetal and neonatal outcomes; paediatric and adult COVID-19 related complications; system-specific COVID-19 complications. For this update, the search focused on meta-analyses and reviews and excluded case reports,

Brighton Collaboration Science Board Election

We would like to announce the upcoming Brighton Collaboration Science Board election. The Science Board meets monthly for one hour to help determine the scientific activities of the Brighton Collaboration. It develops scientific strategies and policies, and decides on new initiatives or re-directing ongoing initiatives. The Science Board also supervises activities and provides scientific advice to working groups and committees. Traditionally, the Board sought to have a balance of members specializing in clinical assessment, regulatory, setting standards, vaccine hesitancy, database,

SPEAC DSMB Pool expansion to non-CEPI developers

As part of its role to support the assessment of safety of vaccines being evaluated in CEPI funded clinical trials, the Safety Platform for Emergency Vaccines (SPEAC) project has been tasked with developing a pool of potential members from the target disease areas that are candidates to serve on the study sponsor Data Safety Monitoring Boards (DSMBs). The goal of this effort was to develop a roster of qualified individuals from each study region, from which study sponsors can select

Task Force Program Plays Key Role in COVID-19 Vaccine Safety Monitoring

Recent news of the possible complications of blood clots – or Thrombosis with Thrombocytopenia Syndrome (TTS) – following the AstraZeneca/Oxford and Johnson & Johnson/Janssen COVID-19 vaccines have raised public concerns and questions about vaccine safety. Once TTS emerged as a safety concern, the Brighton Collaboration was invited by the European Medicines Agency (EMA) to rapidly develop an interim case definition for case finding purposes. As next steps, Brighton is organizing a process to collect and share more complete information on the possible

Benefit-Risk Working Group Call for Members

 The Benefit-Risk Assessment of Vaccines by TechnolOgy (BRAVATO) working group has developed standardized templates for the collection of key information for the development, efficacy, and safety of new vaccine candidates. A template is planned for the collection of key information for a structured B-R approach for vaccines. This will be an additional module that can be appended to the existing BRAVATO vaccine assessment templates or used independently to support these advancements in B-R. See Below to view the full Benefit-Risk Working Group

COVID-19 AESI List 2nd Quarterly Update (December 2020)

SPEAC has completed a second update of the COVID-19 clinical literature covering the period of August 8 through November 13th 2020. Based on this review three entities are being added to the COVID-19 AESI list: subacute thyroiditis, acute pancreatitis and rhabdomyolysis. The full document provides detailed methodology and results related to these additions as well as proposals for laboratory-based definitions of acute kidney and acute liver injury in lieu of new Brighton case definitions. In addition a consolidation of all citations

Brighton Collaboration Added to Vaccine Safety Net

Brighton Collaboration (BC) has been added to the Vaccine Safety Net (VSN). VSN is a global network of websites, established by the World Health Organization (WHO), that provides reliable information on vaccine safety.

New Working Groups to be Established to Develop Guidance on Digital Apps for Vaccine Safety Data Collection

Digital apps have much potential for improving the quality of safety data collected during both pre and post-introduction of new vaccines, including SARS-COV-2 candidate vaccines.Brighton Collaboration (BC) is forming two inter-related working groups (both working together initially) to harmonize this effort as follows: Group A: Clinically-focus on issues like which adverse events following immunizations (AEFI) to include and how to collect this information; building largely on prior BC guidance when possible. Group B: Technology-focus on issues like which app standards to

New Brighton Collaboration Working Groups to be Established to Develop Case Definitions for Four COVID-19 Adverse Events of Special Interest (AESI)

The Coalition for Epidemic Preparedness Innovation (CEPI) has partnered with the Brighton Collaboration to support the safety assessment of its candidate vaccines, including SARS-COV-2.Four AESI have been targeted for case definition development on an urgent prioritized basis over the next 3-4 months.  The specific AESI in order of priority are: Multisystem inflammatory syndrome in children (MIS-C): June 2020 start Acute respiratory distress syndrome (ARDS): June 2020 start Acute cardiovascular injury: July 2020 start Coagulation disorder: July 2020 start It is

Sign up for Brighton Collaboration 2.0 Membership!

Our previous post entitled Transition of Brighton Collaboration informed you of several new developments to strengthen the Brighton Collaboration, including our move to the Task Force for Global Health (TFGH; taskforce.org) in Decatur, GA, USA . For members of the original Brighton Collaboration, we encourage you to maintain your active relationship with Brighton Collaboration throughout this transition. For others, we encourage you to begin a new relationship with Brighton Collaboration and help us build trust in safety of vaccines through rigorous science. Either

CEPI partners with Brighton Collaboration to support safety assessment of vaccine candidates

The Coalition for Epidemic Preparedness Innovations (CEPI) and the Brighton Collaboration, based in Atlanta at The Task Force for Global Health, announced the launch of the Safety Platform for Emergency vACcines (SPEAC) Project on May 28th, 2019.For the full press release, please use the link below:     Alternative Link: CEPI partners with Brighton Collaboration to support safety assessment of vaccine candidates    

Transition of Brighton Collaboration

Dear Partners and Visitors As announced on the 21st of May 2019, the Brighton Collaboration will be dissolved as a Partnership under Swiss law and reconstituted as a programme of the Task Force for Global Health (TFGH; www.taskforce.org). The Swiss Brighton Collaboration Foundation, it’s Foundation Board and Management Team remain available to ensure access to the Academy until the new programme is settled in at TFGH. Click here to see the full BC Communication.